Infusion adapter

ABSTRACT

An infusion adapter for connection with an infusion fluid container includes a connection portion configured to engage an injection port of an infusion fluid container, and a port configured to connect to an intravenous line, with the port in fluid communication with the connection portion. The connection portion includes a retaining ring extending radially outward from the connection portion, with the retaining ring configured to securely connect the infusion adapter to the infusion fluid container to substantially prevent disconnection of the infusion adapter from the infusion fluid container once the infusion adapter is connected to the infusion fluid container. The retaining ring includes an indicator configured to provide visualization of insertion of the connection portion into an injection port of an infusion fluid container.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application Ser.No. 62/101,551, filed Jan. 9, 2015, which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to an infusion adapter and,more particularly, to an infusion adapter for securely connecting theadapter to an intravenous bag for a drug transfer procedure.

2. Description of the Related Art

Intravenous therapy applications allow patients to receive infusion andmedication treatment. For example, therapy may include theadministration of medications by IV using intravenous and subcutaneousor hypodermis routes, i.e., into the bloodstream and under the skin.Examples of medical treatments that intravenous therapy applications mayprovide to a patient include antibiotics, pain management medications,cancer treatments, and similar medications.

Medications may be packaged as “pre-filled” devices, wherein a syringeassembly is pre-filled with medication prior to being packaged anddelivered to a patient. “Pre-filled” devices eliminate the need for auser to fill the device prior to injection.

Certain drugs or medications are preferably provided in powder or dryform (such as a lyophilized form), and require reconstitution prior toadministration. Lyophilized drugs, for example, typically are suppliedin a freeze-dried form that needs to be mixed with a diluent toreconstitute the substance into a form that is suitable for injection.In addition, drugs may be provided as multipart systems that requiremixing prior to administration. For example, one or more liquidcomponents, such as flowable slurries, and one or more dry components,such as powdered or granular components, may be provided in separatecontainers that require mixing prior to administration.

A patient may be provided with an intravenous system that includesintravenous tubing and a connector that is adapted to receive aninjector and/or syringe assembly containing a required medication. Inthis manner, when a treatment is needed, a patient or a medicalpractitioner is able to connect a syringe assembly to the connector andthen inject a medication intravenously into the patient via the injectorand/or syringe assembly, the connector, and the intravenous tubing.

When performing infusion, it is often necessary to inject a drug orother medical substance into the infusion fluid inside an infusion bagor other infusion fluid container. This is often done by means ofpenetrating a septum or other fluid barrier of an injection port on theinfusion bag or on the infusion fluid line with a needle of a syringefilled with the medical fluid in question. However, it has been foundthat an unsecure connection between the syringe and the injection portof the infusion bag may cause problems such as accidental or inadvertentdisconnection of the syringe from the infusion bag, pollution of theworking environment because of leakage, and high forces required topierce a fluid barrier of the injection port of the infusion bag.

SUMMARY OF THE INVENTION

In one aspect, an infusion adapter for connection with an infusion fluidcontainer includes a connection portion configured to engage aninjection port of an infusion fluid container, and a port configured toconnect to an intravenous line, with the port in fluid communicationwith the connection portion. The connection portion includes a retainingring extending radially outward from the connection portion, with theretaining ring configured to securely connect the infusion adapter tothe infusion fluid container to substantially prevent disconnection ofthe infusion adapter from the infusion fluid container once the infusionadapter is connected to the infusion fluid container. The retaining ringincludes an indicator configured to provide visualization of insertionof the connection portion into an injection port of an infusion fluidcontainer.

The indicator may be formed from a first material and a remainingportion of the retaining ring may be formed from a second material, withthe first material being softer than the second material. The firstmaterial may be an elastomeric material, such as a thermoplasticelastomer.

The indicator may extend further radially outward than a remainingportion of the retaining ring. The retaining ring may include a firstside and a second side positioned opposite the first side, where theindicator is annular and positioned between the first side and thesecond side of the retaining ring. The indicator may include a roundedouter portion.

The retaining ring may be positioned adjacent to a stop defined by amain body of the infusion adapter. The retaining ring may have a firstside with a tapered, rounded surface and a second side positionedopposite the first side, with the second side of the retaining ringdefining a sharp edge that is configured to engage a portion of theinfusion fluid container upon an attempt to withdraw the infusionadapter from the infusion fluid container.

The infusion adapter may include a plurality of retaining rings. Theconnection portion may include a puncturing point. Further, the infusionadapter may include a syringe adapter port configured to connect with asyringe adapter. The retaining ring may be crenelated. The indicator maybe formed via a two-shot molding process.

In a further aspect, an infusion adapter for connection with an infusionfluid container includes a connection portion configured to engage aninjection port of the infusion fluid container, and a port configured toconnect with an intravenous line, with the port in fluid communicationwith the connection portion. The connection portion includes a retainingring extending radially outward from the connection portion, with theretaining ring is configured to securely connect the infusion adapter tothe infusion fluid container to substantially prevent disconnection ofthe infusion adapter from the infusion fluid container once the infusionadapter is connected to the infusion fluid container. The retaining ringdefines a plurality of teeth.

The teeth may be defined and spaced apart from each other via recesses.The plurality of teeth and the recesses may each be rectangular inshape. The retaining ring may include a first end and a second endpositioned opposite the first end, with the recesses extending from thesecond end to a position intermediate the first end and the second end.

The retaining ring may be positioned adjacent to a stop defined by amain body of the infusion adapter. The retaining ring may have a firstside with a tapered, rounded surface and a second side positionedopposite the first side, with the second side of the retaining ringdefining a sharp edge that is configured to engage a portion of theinfusion fluid container upon an attempt to withdraw the infusionadapter from the infusion fluid container.

The connection portion may include a puncturing point and the infusionadapter may further include a syringe adapter port configured to connectwith a syringe adapter. The retaining ring may include an indicatorconfigured to provide visualization of insertion of the connectionportion into an injection port of an infusion fluid container.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of an infusion adapter according to oneaspect of the present invention.

FIG. 2 is a right side view of the infusion adapter of FIG. 1 accordingto one aspect of the present invention.

FIG. 2A is an enlarged view of area “2A” shown in FIG. 2 according toone aspect of the present invention.

FIG. 3 is a bottom view of the infusion adapter of FIG. 1 according toone aspect of the present invention.

FIG. 4 is a cross-sectional view along line 4-4 shown in FIG. 3according to one aspect of the present invention.

FIG. 5 is a front view of the infusion adapter of FIG. 1 according toone aspect of the present invention.

FIG. 6 is a rear view of the infusion adapter of FIG. 1 according to oneaspect of the present invention.

FIG. 7 is a cross-sectional view along line 4-4 shown in FIG. 3, showingthe infusion adapter inserted into a port of an infusion fluid containeraccording to one aspect of the present invention.

FIG. 8 is a perspective view of an infusion adapter according to asecond aspect of the present invention.

FIG. 9 is a right side view of an infusion adapter according to a thirdaspect of the present invention.

FIG. 10 is a right side view of an infusion adapter according to afourth aspect of the present invention.

FIG. 11 is a perspective view of an infusion adapter according to afifth aspect of the present invention.

FIG. 12 is a right side view of the infusion adapter of FIG. 11according to an aspect of the present invention.

FIG. 12A is an enlarged view of area “12A” shown in FIG. 12 according toan aspect of the present invention.

FIG. 13 is a perspective view of an infusion adapter according to asixth aspect of the present invention.

FIG. 14 is a right side view of an infusion adapter according to aseventh aspect of the present invention.

FIG. 14A is an enlarged view of area “14A” shown in FIG. 14 according toan aspect of the present invention.

FIG. 15 is a perspective view of an infusion adapter according to aneighth aspect of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

Referring to FIGS. 1-7, an infusion adapter 10 includes a connectionportion 12 located at a first end 14, a first port 16 located at a firstport end 18, and a second port 20 located at a second port end 22.Connection portion 12 includes an anchor component 24 and a fluidchannel 26 and a fluid channel 32, although only a single channelarrangement may also be utilized. First port 16 includes a first portfluid channel 28 and second port 20 includes a second port fluid channel30. As shown more clearly in FIGS. 4 and 7, the fluid channel 32 ofconnection portion 12 is in fluid communication with first port fluidchannel 28 of first port 16 such that a fluid may flow into infusionadapter 10 at first port 16, travel through first port fluid channel 28to fluid channel 32 of connection portion 12 and out first end 14 ofinfusion adapter 10. The fluid channel 26 of connection portion 12 is influid communication with second port fluid channel 30 of second port 20such that a fluid may flow into infusion adapter 10 at first end 14 ofconnection portion 12, travel through fluid channel 26 to second portfluid channel 30 and out second port 20 of infusion adapter 10.

Referring to FIGS. 1-7, in one embodiment, infusion adapter 10 maycomprise a generally Y-shape. Further, it is contemplated that infusionadapter 10 may be made available in a variety of shapes and sizes aslong as first port 16 is spaced a distance from second port 20 so thatfirst port 16 may be connected to a syringe assembly containing amedication fluid and second port 20 may be connected to an intravenousline that is adapted for connection to a bloodstream of a patient aswill be described in more detail below. For example, in anotherembodiment, infusion adapter 10 may comprise a generally T-shape.

Referring to FIG. 4, in one embodiment, infusion adapter 10 may includean intravenous line connector 34 that is removably connectable to a mainbody 36 of infusion adapter 10. In such an embodiment, main body 36includes an intravenous line connector receiving end 38 having a firstconnection portion 40. Additionally, intravenous line connector 34includes a main body receiving end 42 having a second connection portion44. Intravenous line connector 34 includes an end cap 46 that ispivotable via a hinge portion 48 between an open position and a closedposition.

Intravenous line connector 34 may be connected to main body 36 bypositioning main body receiving end 42 of intravenous line connector 34into engagement with intravenous line connector receiving end 38 of mainbody 36. In one embodiment, intravenous line connector 34 may be securedto main body 36 by positioning second connection portion 44 ofintravenous line connector 34 into engagement with first connectionportion 40 of main body 36, and threadingly engaging first connectionportion 40 and second connection portion 44. In other embodiments,second connection portion 44 of intravenous line connector 34 may besecured to first connection portion 40 of main body 36 using apress-fit, locking tapers, interference fit, snap-fit, ball detent,locking tabs, spring loaded locking mechanism, latch, adhesive, or othersimilar mechanism. In this manner, intravenous line connector 34 islocked to main body 36, i.e., significant relative movement betweenintravenous line connector 34 and main body 36 is prevented. Inalternate embodiments, intravenous line connector 34 and main body 36may be integrally formed.

Referring to FIGS. 1-7, connection portion 12 of infusion adapter 10includes anchor component 24 and a puncturing point 60 disposed adjacentfirst end 14. In one embodiment, anchor component 24 includes aretaining ring 50. The retaining ring 50 extends radially outward fromthe connection portion 12 and is positioned adjacent to a stop 52defined by the main body 36 of the infusion adapter 10. A space 54 isprovided between the retaining ring 50 and the stop 52. The retainingring 50 has a first side 56 with a surface that is tapered and roundedand configured to ease insertion of the connection portion 12 andretaining ring 50 into an injection port of an infusion fluid container,such as an intravenous bag, which is shown in FIG. 7, and discussed inmore detail below. A second side 58 of retaining ring 50 positionedopposite the first side 56 has a sharp edge 62 to resist pull out orwithdrawal of the connection portion 12 from the infusion fluidcontainer once inserted therein. A planar surface of the retaining ring50 and the outer radial surface of the retaining ring 50 define thesharp edge 62. The retaining ring 50 is configured to provide additionalretention of the infusion adapter 10 with the port of an infusion fluidcontainer without comprising the leak-proof seal between the adapter 10and the bag. In particular, the retaining ring 50 provides a wedgingaction with the port of the infusion fluid container to further securethe connection portion 12 to the bag while the relatively small profileof the retaining ring 50 maintains the leak-proof seal.

Referring to FIG. 7, the connection portion 12 of the infusion adapter10 is inserted into the port of the infusion fluid container. Uponinsertion, the compliant port of the container engages the connectionportion 12 and the retaining ring 50 with the first side 56 of theretaining ring 50 allowing insertion while creating a wedging effectwith the port. With the anchor component 24 of connection portion 12connected to injection port 104 of the infusion fluid container 102, theanchor component 24 securely connects infusion adapter 10 to theinfusion fluid container 102 such that disconnection of infusion adapter10 from the infusion fluid container 102 is prevented. In this manner,anchor component 24 prevents inadvertent and accidental removal ofinfusion adapter 10 from infusion fluid container 102 and provides aleak-proof connection between infusion adapter 10 and infusion fluidcontainer 102 during a drug transfer procedure. Infusion fluid container102 may also include a second port 108.

In one embodiment, infusion adapter 10 comprises a PhaSeal adapter whichis compatible with a Becton Dickinson (“BD”) PhaSeal™ System availablefrom Becton, Dickinson and Company of Franklin Lakes, N.J.

As previously discussed, intravenous therapy applications allow patientsto receive infusion and medication treatment. For example, therapy mayinclude the administration of medications by IV using intravenous andsubcutaneous or hypodermis routes, i.e., into the bloodstream and underthe skin. Examples of medical treatments that intravenous therapyapplications may provide to a patient include antibiotics, painmanagement medications, cancer treatments, and similar medications.

With infusion adapter 10 securely connected to injection port 104 ofinfusion fluid container 102 via anchor component 24, a patient or amedical practitioner is able to connect a syringe assembly (not shown)to first port 16 of infusion adapter 10. The first port 16 may becompatible with any suitable connection arrangement and any suitablesyringe adapter. With the syringe assembly connected to first port 16, amedication fluid contained in the syringe assembly can be injected intothe infusion fluid container 102 via infusion adapter 10. The syringeassembly may then be disconnected from infusion adapter 10 and theinfusion fluid container 102 may then be sent to nursing and is ready tobe administered to a patient. For example, an intravenous line orintravenous tubing may be connected to second port 20 of infusionadapter 10 with the other end of the intravenous tubing connected to abloodstream of a patient. In this manner, a medication may beadministered to the patient intravenously.

Referring to FIG. 8, an infusion adapter 10A, according to a secondaspect, includes a direct connection with intravenous tubing 110 ratherthan providing the intravenous line connector 34 shown in FIGS. 1-7.

Referring to FIG. 9, an infusion adapter 10B, according to a thirdaspect, includes a direct connection for intravenous tubing and does notinclude the first port 16 shown in FIGS. 1-7.

Referring to FIG. 10, an infusion adapter 10C, according to a fourthaspect, includes a plurality of retaining rings 50A, 50B. One of theretaining rings 50A, 50B may extend further radially outward than one ofthe other retaining rings 50A, 50B. The retaining rings 50A, 50B arespaced apart from each other along a longitudinal direction of theadapter 10C. The retaining ring 50A closest to the puncturing point 60has a smaller diameter and extends less radially outward than the otherretaining ring 50B, although other suitable configurations may beutilized.

Referring to FIGS. 11-12A, an infusion adapter 10D, according to a fifthaspect, includes a retaining ring 50C at least partially defined by aplurality of spaced apart teeth 116. The teeth 116 are defined andspaced from each other via recesses 118. The spaced apart teeth 116 andrecesses 118 may be rectangular in shape. Accordingly, the retainingring 50C of FIGS. 11-12A is crenelated. The retaining ring 50C includesa first end 120 positioned closest to the puncturing point 60 and asecond end 122 positioned opposite the first end 120. The recesses 118extend from the second end 122 to a position intermediate the first end120 and the second end 122. The retaining ring 50C may function in asimilar manner as the retaining ring 50 discussed above in connectionwith FIGS. 1-7 with the spaced apart teeth 116 providing additionalengagement with injection port 104 of infusion fluid container 102.

Referring to FIG. 13, an infusion adapter 10E, according to a sixthaspect, includes a retaining ring 50D having an indicator 112, such as acolored ring-shaped area. The indicator 112 aids in visualizing the fullinsertion of the connection portion 12 into the injection port 104 ofthe infusion fluid container 102. Other suitable visual, tactile,audible, or other types of indications may be utilized.

Referring to FIGS. 14 and 14A, an infusion adapter 10F, according to aseventh aspect, includes a retaining ring 50E having an indicator 112Athat is formed by a two-shot molding process out of an elastomericmaterial, such as a thermoplastic elastomer (TPE). The elastomericmaterial of the indicator 112A further increases the pull-out resistanceof the infusion adapter 1OF from the infusion fluid container 102 byproviding a higher coefficient of friction. The indicator 112A is alsoconfigured to provide visualization of insertion of the connectionportion 12 into the injection port 104 of the infusion fluid container102. In particular, inserting the connection portion 12 into theinjection port 104 of the infusion fluid container 102 such that theindicator 112A is received within the injection port 104 and no longervisible outside the injection port 104 provides an indication to a userthat the connection portion has been fully inserted into the injectionport 104.

The retaining ring 50E, not including the indicator 112A, may be madefrom thermosetting polymers or thermoplastic polymers such aspolypropylene, polyethylene, polystyrene, polycarbonate, acrylics,nylons, or similar materials. The indicator 112A may be annular in shapeand positioned between the first side 56 b and the second side 58 of theretaining ring 50E. The indicator 112A extends further radially outwardthan the remaining portion of the retaining ring 50E. An outer portion124 of the indicator 112A is rounded. As noted above, the indicator 112Amay be made from a material that is softer than the material of theremaining portion of the retaining ring 50E. In particular, theindicator 112A may be made from a material having a Shore A hardnessbetween about 10-100 with the remaining portion of the retaining ring50E being made from a material having a Shore D hardness between about40-100.

Referring to FIG. 15, an infusion adapter 10G, according to an eighthaspect, includes an anchor component 24A that includes a plurality ofbarbs 114 that extend radially outward from the connection portion 12.The plurality of barbs 114 may be molded along with the rest of theconnection portion 12. Each of the plurality of barbs 114 extend awayfrom the first end 14 of the infusion adapter 10 to allow insertion ofthe connection portion 12 into the injection port 104 of the infusionfluid container 102, but prohibiting removing of the connection portion12 from the injection portion 104 after insertions.

Although an indicator arrangement is shown in connection with theinfusion adapters 10E, 10F, each of the other infusion adapters 10, 10A,10B, 10C, 10D, 10G may also include an indicator that is configured toprovide visualization of the insertion of the connection portion 12 intothe injection port 104 of the infusion fluid container 102. Theindicator may be a portion of the connection portion 12 having adifferent color or material than a remaining portion of the connectionportion 12, although other suitable visual, tactile, audible, or othertypes of indications may be utilized.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. An infusion adapter for connection with aninfusion fluid container, the infusion adapter comprising: a connectionportion having a length, the connection portion being configured toengage an injection port of an infusion fluid container along theentirety of the length; and a port configured to connect to anintravenous line, the port in fluid communication with the connectionportion, wherein the connection portion includes a retaining ringcomprising a first side and a second side positioned opposite the firstside, the retaining ring extending radially outward from the connectionportion, the retaining ring configured to be received within theinjection port of the infusion fluid container and securely connect theinfusion adapter to the infusion fluid container to substantiallyprevent disconnection of the infusion adapter from the infusion fluidcontainer once the infusion adapter is connected to the infusion fluidcontainer, wherein the retaining ring includes an indicator configuredto provide visualization of insertion of the connection portion into aninjection port of an infusion fluid container, the indicator having adifferent color and a different material than a remaining portion of theconnection portion, wherein the first side of the retaining ringincludes a tapered, rounded surface, and wherein the second side of theretaining ring defines a sharp edge that is configured to engage aportion of the infusion fluid container to restrain the infusion adapterwith the infusion fluid container upon an attempt to withdraw theinfusion adapter from the infusion fluid container.
 2. The infusionadapter of claim 1, wherein the indicator is formed from a firstmaterial and a remaining portion of the retaining ring is formed from asecond material, and wherein the first material is softer than thesecond material.
 3. The infusion adapter of claim 1, wherein theindicator extends further radially outward than a remaining portion ofthe retaining ring.
 4. The infusion adapter of claim 1, wherein theretaining ring is positioned adjacent to a stop defined by a main bodyof the infusion adapter.
 5. The infusion adapter of claim 1, wherein theconnection portion comprises a puncturing point.
 6. The infusion adapterof claim 1, wherein the indicator is formed via a two-shot moldingprocess.
 7. The infusion adapter of claim 2, wherein the first materialis an elastomeric material.
 8. The infusion adapter of claim 7, whereinthe first material is a thermoplastic elastomer.
 9. The infusion adapterof claim 3, wherein the retaining ring includes a first side and asecond side positioned opposite the first side, and wherein theindicator is annular and positioned between the first side and thesecond side of the retaining ring.
 10. The infusion adapter of claim 3,wherein the indicator includes a rounded outer portion.